A Trial of the Efficacy of Artesunate and Three Quinine Regimens in the Treatment of Severe Malaria in Children at the Ebolowa Regional Hospital - Cameroon

September 30, 2015 updated by: ETHE MAKA Daniel, University of Yaounde 1

A Randomized Trial of the Efficacy of Artesunate and Three Quinine Regimens in the Treatment of Severe Malaria in Children at the Ebolowa Regional Hospital - Cameroon

The purpose of the study is to evaluate and compare the efficacy of parenteral artesunate with three quinine regimens in the treatment of severe malaria in children at the Ebolowa Regional Hospital located in the South region of Cameroon

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children presenting with one or more signs of severity of malaria according to the 2013 Cameroon National Malaria Control Programme adopted criteria (impaired consciousness, abnormal behaviour, convulsions, prostration, persistent vomiting, jaundice, hyperthermia, acute respiratory distress, clinical acidosis, haemoglobinuria, cardiovascular shock, dehydration, abnormal bleeding, severe anaemia, renal impairment, hypoglycaemia and hyperparasitaemia)
  • and having an initial positive parasitaemia to Plasmodium falciparum
  • Other aetiologies of the presenting symptoms excluded
  • Written consent from parent(s)

Exclusion Criteria:

  • Prior side effects to either artesunate or quinine administration
  • Severely malnourished children
  • Concomitant infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ARTES
  • Injectable Artesunate.Each vial contained 60 mg anhydrous artesunic acid, which was dissolved in 1 ml of 5% sodium bicarbonate (provided with the drug) and then mixed with 5 ml saline solution (provided with the drug) before injecting into an indwelling intravenous catheter.
  • Patients received 2.4 mg/kg bw of parenteral artesunate at H0, H12, H24 and thereafter once daily, for a minimum of 24 hours.
  • Patients exited from the protocol if they had clinically recovered and parasitaemia was negative.
Drug: Artesunate
Active Comparator: QLD
  • Injectable quinine. Each vial contained 250 mg or 500 mg QB.
  • Patients received a loading dose of 16.6 mg/kg bw of QB by intravenous (IV) infusion over 4 hours followed 8 hours after the start of the loading dose, with a maintenance dose of QB at 8.3 mg/kg bw over 4 hours every 8 hours diluted in 10 ml/kg bw of 10% dextrose solution.
  • Patients received a minimum of 24 hours of parenteral treatment and exited from the protocol if they had clinically recovered and parasitaemia was negative.
Drug: Quinine
Active Comparator: QNLD3
  • Injectable quinine. Each vial contained 250 mg or 500 mg QB.
  • Patients received 8.3 mg/kg bw of QB over 4 hours by IV infusion every 8 hours diluted in 10 ml/kg bw of 10% dextrose solution.
  • Patients received a minimum of 24 hours of parenteral treatment and exited from the protocol if they had clinically recovered and parasitaemia was negative.
Drug: Quinine
Active Comparator: QNLD2
  • Injectable quinine. Each vial contained 250 mg or 500 mg QB.
  • Patients received 12.5 mg/kg bw of QB over 4 hours by IV infusion every 12 hours diluted in 10 ml/kg bw of 10% dextrose solution.
  • Patients received a minimum of 24 hours of parenteral treatment and exited from the protocol if they had clinically recovered and parasitaemia was negative.
Drug: Quinine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fever clearance time
Time Frame: Time (in hours) from the onset of treatment till rectal temperature went down to 37.5°C for at least 24 hour
Time (in hours) from the onset of treatment till rectal temperature went down to 37.5°C for at least 24 hour
Coma recovery time
Time Frame: Time (in hours) from the onset of treatment till the participant was fully conscious with a BCS of 5 or GCS of 15 for an average of 24 hours
Time (in hours) from the onset of treatment till the participant was fully conscious with a BCS of 5 or GCS of 15 for an average of 24 hours
Time to sit unsupported
Time Frame: Time (in hours) from the onset of treatment till when the participant could sit unsupported for an average of 24 hours if the participant was unable to do so on admission
Time (in hours) from the onset of treatment till when the participant could sit unsupported for an average of 24 hours if the participant was unable to do so on admission
Time to eat and drink
Time Frame: Time (in hours) from the onset of treatment till when the participant could eat and drink for an average of 24 hours if the participant was unable to do so on admission
Time (in hours) from the onset of treatment till when the participant could eat and drink for an average of 24 hours if the participant was unable to do so on admission
Parasite clearance time
Time Frame: Time (in hours) from the onset of treatment to the time of the first of two successive negative blood smear through hospital discharge, an average of one week
Time (in hours) from the onset of treatment to the time of the first of two successive negative blood smear through hospital discharge, an average of one week
Parasite reduction rate 24 hours after onset of treatment
Time Frame: 24 hours from onset of treatment
24 hours from onset of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Yaounde 1

Investigators

  • Study Director: Elie MBONDA, Faculty of Medicine and Biomedical Sciences, University of Yaounde I

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

September 19, 2015

First Submitted That Met QC Criteria

September 28, 2015

First Posted (Estimate)

September 30, 2015

Study Record Updates

Last Update Posted (Estimate)

October 1, 2015

Last Update Submitted That Met QC Criteria

September 30, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UYaounde1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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